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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCLARION MULTI-STRATEGY COCHLEAR IMPLANT
Generic Nameimplant, cochlear
Applicant
ADVANCED BIONICS
28515 westinghouse place
valencia, CA 91355
PMA NumberP960058
Date Received12/30/1996
Decision Date06/26/1997
Product Code MCM 
Docket Number 97M-0396
Notice Date 09/23/1997
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR THE CLARION MULTI-STRATEGY COCHLEAR IMPLANT. THE DEVICE IS INTENDED TO RESTORE A LEVEL OF AUDITORY SENSATION TO CHILDREN WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE. CLARION IS INDICATED FOR THE FOLLOWING: 1)CHILDREN, 2 THROUGH 17 YEARS OF AGE. IF X-RAYS DEMONSTRATE EVIDENCE OF OSSIFICATION, CHILDREN AS YOUNG AS 18 MONTHS MAY BE IMPLANTED; 2)PROFOUND, BILATERAL SENSORINEURAL DEAFNESS; 3)UNDERGONE OR BE WILLING TO UNDERGO A HEARING AID TRAIL WITH APPROPRIATELY FITTED HEARING AIDS; 4)LACK OF BENEFIT FROM APPROPRIATELY FITTING HEARING AIDS. IN YOUNGER CHILDREN, LACK OF BENEFIT WITH HEARING AIDS IS DEFINED AS FAILURE TO ATTAIN BASIC AUDITORY MILESTONES SUCH AS A CHILD'S INCONSISTENT RESPONSE TO HIS/HER NAME IN QUIET OR TO ENVIRONMENTAL SOUNDS (MEANINGFUL AUDITORY INTEGRATION SCALE). IN OLDER CHILDREN, LACK OF AIDED BENEFIT IS DEFINED AS SCORING 0% ON OPEN-SET WORD RECOGNITION (PHONETICALLY BALANCED KINDERGARTEN TEST - WORD LIST) ADMINISTERED WITH MONITORED LIVE-VOICE (70 DB SPL). BOTH YOUNGER AND OLDER CHILDREN SHOULD DEMONSTRATE ONLY MINIMAL ABILITY ON AGE APPROPRIATE OPEN-SET SENTENCE MEASURES AND A PLATEAU IN AUDITORY DEVELOPMENT.
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S009 S010 S011 S012 S013 S014 S015 S020 S021 
S022 S023 S024 S025 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S040 
S042 S043 S045 S046 S047 S048 S049 S050 S053 
S054 S055 S057 S058 S061 S066 S070 S073 S074 
S075 S076 S078 S079 S080 S081 S082 S084 S085 
S087 S089 S090 S091 S092 S093 S094 S095 S096 
S097 S098 S099 S100 S101 S102 S103 S104 S105 
S106 S107 S108 S109 S111 S112 S113 S114 S115 
S116 S117 S118 S119 S120 S121 S122 S123 S124 
S125 S126 S128 S129 S130 S131 S132 S133 S134 
S135 S136 S137 S138 S139 S140 S141 S142 S143 
S144 S145 S146 S147 S148 S150 
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